Transcatheter valve prosthesis delivery system with recapturing feature and method

ABSTRACT

A delivery system for percutaneously deploying a valve prosthesis. The system includes a catheter assembly including a delivery sheath capsule and a handle having an oscillating device. The capsule is configured to compressively retain the valve prosthesis during implantation. After the valve prosthesis is partially exposed during implantation, the oscillating device can create a vibratory motion to reduce the friction between the valve prosthesis and the delivery sheath capsule in order to recapture the valve prosthesis.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention is related to systems and methods for percutaneousimplantation of a heart valve prosthesis.

Background Art

Cardiac valves exhibit two types of pathologies: regurgitation andstenosis. Regurgitation is the more common of the two defects. Eitherdefect can be treated by a surgical repair.

Under certain conditions, the cardiac valve must be replaced. Standardapproaches to valve replacement require cutting open the patient's chestand heart to access the native valve. Such procedures are traumatic tothe patient, require a long recovery time, and can result in lifethreatening complications. Therefore, many patients requiring cardiacvalve replacement are deemed to pose too high a risk for open heartsurgery due to age, health, or a variety of other factors. These patientrisks associated with heart valve replacement are lessened by theemerging techniques for minimally invasive valve repair, but still manyof those techniques require arresting the heart and passing the bloodthrough a heart-lung machine.

Efforts have been focused on percutaneous transluminal delivery ofreplacement cardiac valves to solve the problems presented bytraditional open heart surgery and minimally-invasive surgical methods.In such methods, a valve prosthesis is compacted for delivery in acatheter and then advanced, for example, through an opening in thefemoral artery and through the descending aorta to the heart, where theprosthesis is then deployed in the aortic valve annulus.

Various types and configurations of valve prostheses are available forpercutaneous valve replacement procedures, and continue to be refined.The actual shape and configuration of any particular valve prosthesis isdependent to some extent upon the native shape and size of the valvebeing repaired (i.e., mitral valve, tricuspid valve, aortic valve, orpulmonary valve). In general, valve prosthesis designs attempt toreplicate the functions of the valve being replaced and thus willinclude valve leaflet-like structures. A typical percutaneous valveprosthesis includes a replacement valve that is mounted in some mannerwithin an expandable stent frame to make a valved stent (or “valveprosthesis”). For many percutaneous delivery and implantation devices,the stent frame of the valved stent is made of a self-expanding materialand construction. With these devices, the valved stent is crimped downto a desired size and held in that compressed arrangement within anouter sheath, also known as a capsule, for example. Retracting thesheath from the valved stent allows the stent to self-expand to a largerdiameter, such as when the valved stent is in a desired position withina patient. In other percutaneous implantation devices, the valved stentcan be initially provided in an expanded or uncrimped condition, thencrimped or compressed on a balloon portion of catheter until it is asclose to the diameter of the catheter as possible. Once delivered to theimplantation site, the balloon is inflated to deploy the prosthesis.With either of these types of percutaneous stented valve prosthesisdelivery devices, conventional sewing of the valve prosthesis to thepatient's native tissue is typically not necessary.

It is imperative that the stented valve prosthesis be accurately locatedrelative to the native annulus immediately prior to full deployment fromthe catheter as successful implantation requires the valve prosthesisintimately lodge and seal against the native annulus. If the prosthesisis incorrectly positioned relative to the native annulus, seriouscomplications can result as the deployed device can leak and can evendislodge from the native valve implantation site.

While imaging technology can be employed as part of the implantationprocedure to assist a clinician in better evaluating a location of thetranscatheter valve prosthesis immediately prior to deployment, in manyinstances, this evaluation alone is insufficient. Instead, cliniciansdesire the ability to partially deploy the prosthesis, evaluate aposition relative to the native annulus, and then reposition theprosthesis prior to full deployment if deemed necessary. Repositioning,in turn, requires the prosthesis first be re-compressed and re-locatedback within the outer delivery sheath. Stated otherwise, the partiallydeployed stented valve prosthesis must be “recaptured” by the deliverydevice, and in particular within the outer sheath. While, in theory, therecapturing of a partially deployed stented valve prosthesis is straightforward, in actual practice, the constraints presented by theimplantation site and the stented heart valve itself render thetechnique exceedingly difficult.

For a self-expanding device, the stented heart valve is submerged incold water in order to attach the stented heart valve onto the deliverysystem. This is because the shape memory material, typically Nitinol, isflexible at low temperatures. At warmer temperatures, for example insidethe human body, the shape memory material becomes more rigid. In short,the stented heart valve is purposefully designed to rigidly resistcollapsing forces once deployed to properly anchor itself in the anatomyof the heart. Thus, the delivery device component (e.g., outer deliverysheath) employed to force a partially-deployed segment of the prosthesisback to a collapsed arrangement must be capable of exerting asignificant radial force. Conversely, however, the component cannot beoverly rigid so as to avoid damaging the transcatheter heart valve aspart of a recapturing procedure. Along these same lines, the aortic archmust be traversed, necessitating that the delivery device providesufficient articulation attributes.

As mentioned above, an outer sheath or catheter is conventionallyemployed to deliver a self-deploying vascular stent. For the delivery ofa self-deploying stented valve prosthesis, the high radial expansionforce associated with the prosthesis is not problematic for completedeployment as the outer sheath is simply retracted in tension to allowthe valve prosthesis to deploy. Were the conventional delivery deviceoperated to only partially withdraw the outer sheath relative to theprosthesis, only the so-exposed distal region of the prosthetic wouldexpand while the proximal region remained coupled to the deliverydevice. In theory, the outer sheath could simply be advanced distally torecapture the expanded region. Unfortunately, with conventional sheathconfigurations, attempting to compress the expanded region of thestented valve prosthesis by distally sliding the sheath is unlikely tobe successful. The conventional delivery sheath cannot readily overcomethe radial force of the expanded region of the prosthesis because, ineffect, the sheath is placed into compression and will collapse due atleast in part to the abrupt edge of the sheath being unable to cleanlyslide over the expanded region of the prosthesis.

BRIEF SUMMARY OF THE INVENTION

Provided herein is a valve prostheses delivery system that generallyincludes a delivery system having a handle at a proximal end and acapsule at a distal end. The capsule surrounds a compressed valveprosthesis for delivery through a patient's vasculature. The handleincludes an oscillating device that induces a vibratory motion on thedelivery system. Such a configuration achieves numerous goals. Forexample, such a configuration allows for a reduction in the frictioncoefficient between the outer surface of the valve prosthesis and theinner surface of the capsule during recapture of the valve prosthesis.This configuration also allows for a reduction in the axial forcerequired to recapture the valve prosthesis.

In view thereof, disclosed herein are aspects of a delivery deviceincluding a sheath and an oscillator configured to transmit vibratorymotion to a sheath at a defined frequency.

In another exemplary embodiment, disclosed herein are aspects of adelivery system including a sheath and an ultrasonic device configuredto transmit ultrasonic energy at a defined frequency to the sheath toinduce a vibratory motion.

In another exemplary embodiment, disclosed herein are aspects of amethod of treating a valve disorder in a patient's heart includingdelivering a compressed valve prosthesis attached to a delivery deviceto an implantation site, the delivery device including a capsule thatcompressively contains the valve prosthesis, and proximately retractingthe capsule relative to the compressed valve prosthesis to expose aregion of the valve prosthesis such that the exposed region expands toan uncompressed state, applying a vibration to the capsule andproximally advancing the valve prosthesis relative to the deliverydevice to cause the exposed region of the valve prosthesis to transitiontoward a compressed arrangement within an interior area of the capsule,and proximately retracting the capsule relative to the compressed valveprosthesis to deploy the valve prosthesis at the implantation site.

BRIEF DESCRIPTION OF THE DRAWINGS/FIGURES

The accompanying figures, which are incorporated herein, form part ofthe specification and illustrate embodiments of a valve prosthesisdelivery system. Together with the description, the figures furtherserve to explain the principles of and to enable a person skilled in therelevant art(s) to make, use, and implant a valve prosthesis using thevalve prosthesis delivery system described herein. In the drawings, likereference numbers indicate identical or functionally similar elements.

FIG. 1 is a sectional view of a valve prosthesis delivery systemaccording to an aspect of this disclosure.

FIG. 2 is a simplified sectional view of a valve prosthesis deliverysystem according to an aspect of this disclosure.

FIG. 3 is a simplified sectional view of a valve prosthesis deliverysystem according to an aspect of this disclosure.

FIG. 4 is a simplified sectional view of a valve prosthesis deliverysystem according to an aspect of this disclosure.

FIG. 5 is a simplified sectional view of a valve prosthesis deliverysystem according to an aspect of this disclosure.

FIG. 6 is a simplified sectional view of a valve prosthesis deliverysystem according to an aspect of this disclosure.

FIG. 7 is a simplified sectional view of a valve prosthesis deliverysystem according to an aspect of this disclosure.

FIG. 8 is a side view of a valve prosthesis delivery system according toan aspect of this disclosure.

FIG. 9 is a perspective view of a valve prosthesis delivery systemaccording to an aspect of this disclosure.

FIG. 10 is a magnified perspective view of a valve prosthesis deliverysystem according to an aspect of this disclosure.

FIG. 11 is a simplified sectional view of a portion of a valveprosthesis delivery system positioned on an axis 150 according to anaspect of this disclosure.

FIG. 12 is a simplified sectional view of a portion of a valveprosthesis delivery system positioned on an axis 150 according to anaspect of this disclosure.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description of a valve prosthesis delivery systemrefers to the accompanying figures that illustrate exemplaryembodiments. Other embodiments are possible. Modifications can be madeto the embodiments described herein without departing from the spiritand scope of the present invention. Therefore, the following detaileddescription is not meant to be limiting.

The present invention is directed to a heart valve prosthesis deliverysystem including an oscillating device to transmit vibratory motionalong the delivery system. The vibratory motion can be used to reducefriction between surfaces, which is commonly known as applying a“dither.” Friction of two objects in vibration can reduce the frictioncoefficient and friction forces between the two objects, lighten theabrasion between the objects, reduce energy consumption, and greatlyincrease working efficiency. In the present invention, the recaptureforces in the delivery system are reduced by applying a vibrationbetween the inner surface of the delivery system capsule, which housesthe valve prosthesis during delivery, and the outer surface of the valveframe. In a further aspect of the invention, the vibration can create acoordinated traveling wave within the delivery system capsule structurethus making the recapture process peristaltic.

The delivery system delivers a valve prosthesis percutaneously to theheart to replace the function of a native valve. For example, the valveprosthesis can replace a bicuspid or a tricuspid valve such as theaortic, mitral, pulmonary, or tricuspid heart valve. The valve can bedelivered, for example, transfemorally, transeptally, transapically,transradially, transsubclavian, or transatrially.

Valve prostheses typically have a coupling feature to attach the valveprostheses to a delivery system. The coupling feature typically attachesto a corresponding feature on the delivery system which retains thevalve prosthesis. In addition, valve prosthesis delivery systemstypically include a sheath, referred to herein as a sheath or capsule,that surrounds the collapsed valve prosthesis during delivery to theimplantation site. During deployment, the capsule is withdrawn over thevalve prosthesis.

Referring now to FIGS. 1-6, the delivery system for valve prosthesis 1includes catheter assembly 110 that includes an outer sheath 112, apusher tube 114, and a central tube 118, each of which areconcentrically aligned and permit relative motion with respect to eachother. Catheter assembly 110 also includes a guidewire lumen providedfor guidewire 128. At a distal end of pusher tube 114 is a capsule 116.At a distal end of central tube 118 is plunger assembly 120. Capsule 116surrounds plunger assembly 120 and collapsed valve prosthesis 1 duringdelivery of valve prosthesis 1. Plunger assembly 120 includes hub 122 ata proximal end and tip 126 at a distal end. Tip 126 facilitates theadvancement of catheter assembly 110 through the patient's vasculature.Hub 122 includes attachments 124 (referenced generally) configured toselectively capture a corresponding attachment feature of the valveprosthesis. Attachments 124 can assume various forms. In one aspect,attachments 124 are geometric tabs sized to receive a correspondingcomponent(s) of the valve prosthesis. In an alternate aspect,attachments 124 form one or more slots sized to slidably receive acorresponding component(s) of the valve prosthesis (e.g., a bar or legsegment of the stent frame). Further, the plunger assembly 120 canincorporate additional structures and/or mechanisms that assist intemporarily retaining the stented valve (e.g., a tubular sleeve biasedover the hub 122). A non-limiting example of a plunger assembly usefulwith the present disclosure is described in U.S. application Ser. No.12/870,567 entitled “Transcatheter Valve Delivery Systems and Methods”filed Aug. 27, 2010, which is incorporated herein by reference in itsentirety. Other releasable coupling arrangements are also acceptable,such as hub 122 including one or more fingers sized to be receivedwithin corresponding apertures formed by the valve prosthesis stentframe (e.g., the valve prosthesis stent frame can form wire loops at aproximal end thereof that are received over respective ones of thefingers when compressed within capsule 116).

In one aspect of the invention, a shape memory (e.g., Nitinol) structureis incorporated into capsule 116. This allows a portion of capsule 116to expand circumferentially or flare at a distal end thereof whenencountering the outward radial forces (or resistance to radialcompression) of the transcatheter valve prosthesis 1 during deploymentand recapture. The expanded structure reduces the peak forces requiredto collapse the cells of a stent frame of valve prosthesis 1 byredistributing the potential energy along a length of the expandedflare. One non-limiting example of a flared delivery system capsuleuseful with the present disclosure is described in U.S. PatentPublication No. 2011/0251681, which is incorporated herein by referencein its entirety.

In general terms, the stented valve prostheses of the present disclosureinclude a stent or stent frame maintaining a valve structure (tissue orsynthetic), with the stent having a normal, expanded arrangement andcollapsible to a compressed arrangement for loading within a deliverydevice. The stent is normally constructed to self-deploy or self-expandwhen released from the delivery device. For example, the stented valveprosthesis useful with the present disclosure can be a prosthetic valvesold under the trade name CoreValve® available from Medtronic CoreValve,LLC. Other non-limiting examples of transcatheter heart valve prosthesesuseful with systems, devices, and methods of the present disclosure aredescribed in U.S. Publication Nos. 2006/0265056; 2007/0239266; and2007/0239269, which are incorporated herein by reference in theirentirety.

The stents or stent frames are support structures that comprise a numberof struts or wire portions arranged relative to each other to provide adesired compressibility and strength to the valve prosthesis. In generalterms, the stents or stent frames of the present disclosure aregenerally tubular support structures having an internal area in whichvalve structure leaflets will be secured. The leaflets can be formedfrom a variety of materials, such as autologous tissue, xenographmaterial, or synthetics as are known in the art. The leaflets can beprovided as a homogenous, biological valve structure, such as porcine,bovine, or equine valves. Alternatively, the leaflets can be providedindependent of one another (e.g., bovine or equine pericardial leaflets)and subsequently assembled to the support structure of the stent frame.In another alternative, the stent frame and leaflets can be fabricatedat the same time, such as can be accomplished using high-strengthnano-manufactured NiTi films produced at Advance BioProsthetic Surfaces(ABPS), for example. The stent frame support structures are generallyconfigured to accommodate at least two (typically three) leaflets;however, stented valve prostheses of the types described herein canincorporate more or less than three leaflets.

Delivery system 100 also includes a valve prosthesis 1 and a handle 200.As shown, valve prosthesis 1 collapsed and loaded onto delivery system100. Valve prosthesis 1 is crimped onto the plunger assembly 120 suchthat valve prosthesis 1 engages attachments 124. Capsule 116compressively contains valve prosthesis 1 in the compressed arrangement.As discussed, capsule 116 is configured to permit partial and completedeployment of valve prosthesis 1 from the loaded state, as well as torecapture valve prosthesis 1 following partial deployment.

Handle 200 includes an actuation portion 202. Actuation portion 202 iscoupled to pusher tube 114 and is configured to move pusher tube 114 andcapsule 116 relative to central tube 118 and plunger assembly 120. Inone aspect of the invention, actuation portion 202 can be moved toward aproximal end of handle 200 in order to move pusher tube 114 and capsule116 relative to central tube 118 to permit partial or completedeployment of valve prosthesis 1. In a further aspect of the invention,actuation portion 202 can be moved from a proximal end of handle 200 toa distal end of handle 200 in order to move pusher tube 114 and capsule116 relative to central tube 118 to recapture valve prosthesis 1. Handle200 also includes an oscillating device 210 to transmit vibratory motionto capsule 116 during recapture of valve prosthesis 1.

To deploy valve prosthesis 1 from delivery system 100, capsule 116 iswithdrawn from over valve prosthesis 1, for example by proximallyretracting pusher tube 114 and capsule 116 by operating actuationportion 202 toward the proximal end of handle body 204, such that thecapsule distal end is proximal to attachments 124. Once capsule 116 isproximal the attachments 124, valve prosthesis 1 is allowed toself-expand to a natural arrangement thereby releasing from deliverysystem 100.

In some instances, a clinician can desire to only partially deploy valveprosthesis 1 and then evaluate positioning before fully releasing valveprosthesis 1. For example, delivery system 100 loaded with valveprosthesis 1 can be employed as part of a method to repair a damagedheart valve of a patient. Under these circumstances, delivery system100, in the loaded state, is advanced toward the native heart valveimplantation target site, for example in a retrograde approach, througha cut-down to the femoral artery and into the patient's descendingaorta. Delivery system 100 is then advanced using tip 126, underfluoroscopic guidance, over the aortic arch, through the ascendingaorta, and midway across the defective aortic valve (for aortic valvereplacement).

Once positioning of delivery system 100 is estimated, pusher tube 114and capsule 116, are partially retracted relative to valve prosthesis 1as shown in FIG. 3. In particular, a force as indicated by arrow 130 isapplied to actuation portion 202 to slide actuation portion 202 toward aproximal end of handle 200. A distal region of valve prosthesis 1 isthus exteriorly exposed relative to capsule 116 and self-expands. In thepartially deployed arrangement of FIG. 3, however, at least a proximalregion of valve prosthesis 1 remains within an interior area of capsule116, and thus coupled to delivery system 100. As shown in FIG. 4,further operation of actuation portion 202 due to a force indicated byarrow 132 that moves actuation portion 202 toward a proximal end ofhandle 200 exposes a larger distal region of valve prosthesis 1 whereasa small proximal region remains within an interior area of capsule 116.In this partially deployed state, a position of valve prosthesis 1relative to the desired implantation site can again be evaluated.

In the event the clinician believes, based upon the above evaluation,that valve prosthesis 1 should be repositioned relative to theimplantation site, valve prosthesis 1 must first be contracted and“resheathed” by transitioning delivery system 100 to a recapturingstate. As shown in FIG. 5, oscillating device 210 is activated to inducevibratory motion and actuation portion 202 is moved distally to advancepusher tube 114 and capsule 116 relative to valve prosthesis 1 andcentral tube 118, as indicated by arrow 134. The vibratory motioncreated by oscillating device 210 reduces the friction between the outersurface of valve prosthesis 1 and the inner surface of capsule 116.Furthermore, distal advancement of actuation portion 202 causes capsule116 to be maneuvered into contact with the exposed distal region ofvalve prosthesis 1. Thus, capsule 116 readily slides along a surface ofvalve prosthesis 1.

Distal advancement of capsule 116 continues until capsule 116 enclosesvalve prosthesis 1, as shown in FIG. 6. The capsule 116 is distallyadvanced to a recapturing state, forming an enclosed region that can berepositioned and/or retracted.

Once valve prosthesis 1 is recaptured, delivery system 100 can berepositioned relative to the implantation site, and the process repeateduntil the clinician is comfortable with the achieved positioning.Alternatively, the resheathed valve prosthesis 1 can be removed from thepatient.

As discussed above, the recapture of valve prosthesis 1 can befacilitated by oscillating device 210. Oscillating device 210 createsvibratory motion between the inner surface of capsule 116 and the outersurface of valve frame 10 in order to reduce the friction between thesurfaces and thus reduce the peak force required to recapture apartially deployed valve prosthesis 1.

In one aspect of the invention, oscillating device 210 can transmitvibratory motion to delivery system 100 including catheter assembly 110.In a further aspect, oscillating device 210 can transmit vibratorymotion to capsule 116, to valve prosthesis 1, or to both capsule 116 andvalve prosthesis 1 in order to reduce the frictional forces betweencapsule 116 and valve prosthesis 1. Such a reduction in friction betweensurfaces can be useful, for example, during recapture of valveprosthesis 1. Furthermore, this vibratory motion can reduce therecapture forces exerted on the delivery system during recapture ofvalve prosthesis 1.

In one aspect, oscillating device 210 can induce a vibratory motion ontodelivery system 100 at a frequency that is outside the audible range.For example, oscillating device 210 can induce a vibratory motion at afrequency that is less than or approximately equal to 20 hertz orgreater than or approximately equal to 20,000 hertz. In an alternateaspect, oscillating device 210 can induce a vibratory motion ontodelivery system 100 at a frequency of approximately 260 hertz. Thevibratory motion created by oscillating device 210 can be axial, radial,or a combination of radial and axial motion. In a further aspect of theinvention, oscillating device 210 can induce a vibratory motion ontodelivery system 100 at the natural frequency of pusher tube 114 andcapsule 116. In an alternate aspect, oscillating device 210 can induce avibratory motion onto delivery system 100 at the natural frequency ofcentral tube 118 and plunger assembly 120.

In one aspect of the invention, oscillating device 210 is positioned onactuation portion 202 on handle 200. In an alternate aspect of theinvention, oscillating device 210 can be positioned separate fromactuation portion 202, proximal to or distal to actuation portion 202 onhandle 200. Oscillation device 210 can also be separate from deliverysystem 100 as discussed further below. Oscillating device 210 cantransmit vibratory motion to pusher tube 114 and capsule 116. In analternate aspect of the invention, oscillating device 210 can transmitvibratory motion to central tube 118 and plunger assembly 120 includingcollapsed valve prosthesis 1. In a further aspect, oscillating device210 can transmit vibratory motion to pusher tube 114, capsule 116,central tube 118 and plunger assembly 120 including collapsed valveprosthesis 1.

Delivery system 100 can also include a generator or other power source(not shown) to supply electricity to oscillating device 210. Oscillatingdevice 210 can also include an activation button 212. Activation button212 can be a switch or other device to enable oscillating device 210 tobegin transmitting vibratory motion during recapture. In one aspect,activation button 212 is positioned on handle 200. For example,activation button 212 can be positioned on oscillating device 210 or onactuation portion 202. In another aspect, activation button 212 can beseparate from handle 200 and can be, for example, a foot switch.

In one aspect of the invention, oscillating device 210 can includepiezoelectrics. Piezoelectrics are ceramic materials that, by virtue oftheir crystallographic structure, produce a voltage in response to anapplied stress. Conversely, an applied voltage causes a strain withinthe piezoelectric material. If the electrical input is rapidlyalternated, a high-frequency vibration of the piezoelectric material canbe created. In one aspect, oscillating device 210 includingpiezoelectrics, that can be positioned on handle 200 and delivery system100. In this aspect, vibratory motion is transferred along pusher tube114 to capsule 116 and/or along central tube 118 to plunger assembly 120including valve prosthesis 1.

Referring to FIGS. 11-12, delivery system 100 can include an axialpushrod 310 and an annular o-ring 320. In one aspect, axial pushrod 310is connected to oscillating device 210 positioned on handle 200.Oscillating device 210 transmits alternating axial motion along axialpushrod 310 which in turn compresses and relaxes o-ring 320. Thisalternating axial motion is converted to alternating radial expansionand contraction of o-ring 320. O-ring 320 transmits radial vibration tocapsule 116 as a result of the alternating expansion and contraction ofo-ring 320. In an alternate aspect of the invention, o-ring 320 cantransmit radial vibration to the portion of frame 10 that remainscollapsed within capsule 116 during recapture.

In an alternate aspect of the invention, oscillating device 210including piezoelectrics can be positioned within or directly adjacentto capsule 116 at a distal end of pusher tube 114. In a further aspect,oscillating device 210 including piezoelectrics can be positioned withinor directly adjacent to plunger assembly 120 at a distal end of centraltube 118.

In order to supply the necessary voltage to the piezoelectrics inoscillating device 210, delivery system 100 can include a generator orother power source to supply power to oscillating device 210. Thegenerator can send an electrical signal through a conductor (not shown)at a selected amplitude, frequency, and phase to cause thepiezoelectrics in oscillating device 210 to expand and contract, therebyconverting the electrical energy into mechanical motion. The generatorcan also include a control system to determine the appropriateamplitude, frequency, and phase. In one aspect of the invention, thepiezoelectrics in oscillating device 210 are a piezoelectric bimorphconsisting of a piezoelectric layer and a metal layer. An electric fieldprovided by the generator causes one layer to extend and the other layerto contract.

In an alternate aspect of the invention, oscillating device 210 is notpositioned on delivery system 100. In this aspect, oscillating device210 can be an intracardiac catheter or an intravenous ultrasoundcatheter placed in close proximity to capsule 116 of delivery system 100during recapture. The intracardiac catheter or intravenous ultrasoundcatheter can transmit ultrasonic energy at an appropriate frequency inorder to induce vibratory motion in capsule 116. Non-limiting examplesof intracardiac catheters and intravenous ultrasound catheters usefulwith systems, devices, and methods of the present disclosure aredescribed in U.S. Pat. Nos. 6,375,615; 6,660,024; 7,637,870 and U.S.Publication No. 2011/0224596, which are incorporated herein by referencein their entirety.

In an alternate aspect of the invention, oscillating device 210 caninduce vibratory motion mechanically. Referring now to FIGS. 9-10,oscillating device 210 can include a motor 224, a cam 220, and a link222. In this aspect, motor 224 can be connected to handle body 204. In afurther aspect, motor 224 can be permanently attached to handle body 204through screws, adhesive, or other attachment means. Motor 224 isconnected to a generator or other power source (not shown) and includesan output shaft connected to cam 220. Cam 220 is connected to link 222and link 222 is connected to pusher tube 114 or central tube 118.Retaining slot 223 is provided in handle body 204 to allow link 222 toconnect to pusher tube 114 or central tube 118. As motor 224 rotates,cam 220 induces motion on link 222 causing link 222 to move up and downwithin retaining slot 223. Link 222 in turn induces a vibratory motiononto pusher tube 114 and capsule 116. Motor cover 226 surrounds themotor 224, link 222, and cam 220 on handle 200. In one aspect of theinvention, actuation portion 202 includes activation button 212 whichcontrols the activation of motor 224. In an alternate aspect of theinvention, activation button 212 can be connected to motor cover 226. Ina further aspect, motor 224, link 222, and cam 220 are connected toactuation portion 202.

In a further aspect of the invention, oscillating device 210 can inducevibratory motion through magnetism. For example, vibratory motion can becreated by rotating a surface having an alternating charge by astationary magnet. In an alternate aspect, oscillating device 210 caninclude an electromagnet, a power source, and a magnet assembly toinduce vibratory motion onto pusher tube 114 and capsule 116.

Implantation of the valve prosthesis will now be described. As discussedabove, the valve prosthesis preferably comprises a self-expanding framethat can be compressed to a contracted delivery configuration onto aninner member of a delivery catheter. This frame design requires aloading system to crimp valve prosthesis 1 to the delivery size, whileallowing the proximal end of valve prosthesis 1 to protrude from theloading system so that the proximal end can be attached to attachments124.

The valve prosthesis and inner member can then be loaded into a deliverysheath of conventional design, e.g., having a diameter of less than20-24 French.

The delivery catheter and valve prosthesis can then be advanced in aretrograde manner through the femoral artery and into the patient'sdescending aorta. The catheter then is advanced, under fluoroscopicguidance, over the aortic arch, through the ascending aorta and mid-wayacross the defective aortic valve. Once positioning of the catheter isconfirmed, capsule 116 can be withdrawn proximally, thereby permittingvalve prosthesis 1 to self-expand.

As the valve prosthesis expands, it traps the leaflets of the patient'sdefective aortic valve against the valve annulus, retaining the nativevalve in a permanently open state. The outflow section of the valveprosthesis expands against and aligns the prosthesis within theascending aorta, while the inflow section becomes anchored in the aorticannulus of the left ventricle, so that the skirt reduces the risk ofperivalvular leaks. As discussed above, recapture of valve prosthesis 1can be accomplished if necessary.

Alternatively, the valve prosthesis can be delivered through atransapical procedure. In a transapical procedure, a trocar or overtubeis inserted into the left ventricle through an incision created in theapex of a patient's heart. A dilator is used to aid in the insertion ofthe trocar. In this approach, the native valve (e.g. the mitral valve)is approached from the downstream relative to the blood flow. The trocaris retracted sufficiently to release the self-expanding valveprosthesis. The dilator is preferably presented between the valveleaflets. The trocar can be rotated and adjusted as necessary toproperly align the valve prosthesis. The dilator is advanced into theleft atrium to begin disengaging the proximal section of the valveprosthesis from the dilator.

In an alternate aspect of the invention, the valve prosthesis can bedelivered through a transatrial procedure. In this procedure, thedilator and trocar are inserted through an incision made in the wall ofthe left atrium of the heart. The dilator and trocar are advancedthrough the native valve and into the left ventricle of heart. Thedilator is then withdrawn from the trocar. A guide wire is advancedthrough the trocar to the point where the valve prosthesis comes to theend of the trocar. The valve prosthesis is advanced sufficiently torelease the self-expanding frame from the trocar. The trocar can berotated and adjusted as necessary to properly align the valveprosthesis. The trocar is completely withdrawn from the heart such thatthe valve prosthesis self-expands into position and assumes the functionof the native valve.

The foregoing description has been presented for purposes ofillustration and enablement, and is not intended to be exhaustive or tolimit the invention to the precise form disclosed. Other modificationsand variations are possible in light of the above teachings. Theembodiments and examples were chosen and described in order to bestexplain the principles of the invention and its practical applicationand to thereby enable others skilled in the art to best utilize theinvention in various embodiments and various modifications as are suitedto the particular use contemplated. It is intended that the appendedclaims be construed to include other alternative embodiments of theinvention.

What is claimed is:
 1. A delivery device comprising: a sheath; a handleincluding a body coupled to the sheath; an oscillator configured totransmit vibratory motion to the sheath at a defined frequency, whereinthe oscillator is positioned on the handle; an inner shaft assemblyincluding an inner shaft and a coupling structure configured toselectively engage a valve prosthesis, the inner shaft assembly beingcoupled to the body; and a sheath capsule connected to the sheath, thecapsule being slidably disposed over the inner shaft assembly andconfigured to compressively contain the valve prosthesis engaged withthe coupling structure, wherein the oscillator is further configured totransmit vibratory motion to the sheath as the sheath is advanced torecapture a partially deployed valve prosthesis in order to reducefriction between an inner surface of the sheath capsule and an outersurface of the valve prosthesis.
 2. The delivery device of claim 1,wherein the body is attached to the oscillator.
 3. The delivery deviceof claim 1, wherein the oscillator includes a piezoelectric material. 4.The delivery device of claim 1, wherein the oscillator includes amagnet.
 5. The delivery device of claim 4, wherein the oscillatorincludes a rotating surface configured to have an alternating charge. 6.The delivery device of claim 1, wherein the oscillator includes a motorattached to the body.
 7. The delivery device of claim 6, wherein theoscillator includes a rotating cam attached to a motor output shaft. 8.The delivery device of claim 7, wherein the rotating cam is connected tothe sheath.
 9. The delivery device of claim 7, wherein the rotating camis connected to the inner shaft assembly.
 10. The delivery device ofclaim 1, wherein the inner shaft assembly includes a motion converterlocated proximal to the coupling structure, and wherein the motionconverter is configured to expand and contract with axial motiontransmitted by the oscillator to impart radial motion onto the innersurface of the capsule.
 11. The delivery device of claim 1, wherein thehandle includes an actuation mechanism coupled to the sheath such thatmovement of the actuation mechanism causes the sheath to move relativeto the inner shaft assembly.
 12. The delivery device of claim 11,wherein the oscillator is coupled to the actuation mechanism.
 13. Thedelivery device of claim 1, wherein the oscillator is an ultrasonicdevice configured to transmit ultrasonic energy to the sheath to inducethe vibratory motion.
 14. The delivery device of claim 1, wherein theoscillator device is configured to transmit a radial vibratory motion atthe defined frequency to the sheath.
 15. A percutaneous valve prosthesisdelivery system comprising: a valve prosthesis including a stent and avalve leaflet structure coupled to the stent; a sheath, wherein thevalve prosthesis is radially compressed and disposed within the sheathin a delivery configuration for delivery to a native heart valve,wherein the sheath is configured to be retracted to a partially deployedconfiguration wherein a portion of the valve prosthesis is disposedwithin the sheath and a portion of the valve prosthesis is outside ofthe sheath and radially expanded; a handle including a body coupled tothe sheath; an inner shaft assembly including an inner shaft and acoupling structure, wherein the coupling structure engages the valveprosthesis in the delivery configuration; and an oscillator devicepositioned on the handle and configured to transmit a vibratory motionat a defined frequency to the sheath as the sheath is advanced from thepartially deployed configuration to the delivery configuration.
 16. Thepercutaneous valve prosthesis delivery system of claim 15, wherein theoscillator is an ultrasonic device configured to transmit ultrasonicenergy to the sheath to induce the vibratory motion.
 17. Thepercutaneous valve prosthesis delivery system of claim 15, wherein thehandle includes an actuation mechanism coupled to the sheath such thatmovement of the actuation mechanism causes the sheath to move relativeto the inner shaft assembly.
 18. The percutaneous valve prosthesisdelivery system of claim 17, wherein the oscillator is coupled to theactuation mechanism.
 19. The percutaneous valve prosthesis deliverysystem of claim 15, wherein the oscillator device is configured totransmit a radial vibratory motion at the defined frequency to thesheath.